HuMax-IL8 (Interleukin8) in Patients With Advanced Malignant Solid Tumors

All human subjects with a diagnosis of incurable solid tumors are eligible for the
dose-escalation phase of this study. This study consists of two phases, the dose-escalation
phase and the expansion phase. Subjects will be treated with the study treatment until any
off-treatment criteria are met. The safety and efficacy will be assessed until the end of
treatment or for a maximum of 52 weeks. In addition, a separate visit will be performed at
the time of disease progression if the patient has a progression between end of treatment
and 52 weeks. The patients will be followed up for overall survival until the study closure.
The study will be closed when all enrolled patients have been followed up for at least 52
weeks or have died.

Inclusion Criteria:

- Subjects must have metastatic or unresectable locally advanced malignant solid tumor.

- Patients may have measurable or non-measurable but evaluable disease.

- Patients with surgically resected metastatic disease at high risk of relapse are also
eligible.

- Patients must have completed or had disease progression on at least one prior line of
disease-appropriate therapy for metastatic disease, or not be candidates for therapy
of proven efficacy for their disease.

- Patients must have recovered (grade 1 or baseline) from any clinically significant
toxicity associated with prior therapy

- Age ≥ 18 years. .

- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1 (Karnofsky ≥ 70%).

- Patients must have normal organ and hematologic function therapy

- Patients must have baseline pulse oximetry > 90% on room air

Exclusion Criteria:

- Pregnant women or women presently breast-feeding

- Concurrent treatment for cancer

- Chronic hepatitis B or C infection.

- Any significant disease that, in the opinion of the investigator, may impair the
patient's tolerance of study treatment.

- Significant dementia, altered mental status, or any psychiatric condition that would
prohibit the understanding or rendering of informed consent.

- Active autoimmune diseases requiring treatment or a history of autoimmune disease.

- Concurrent use of systemic steroids

- Patients who are receiving any other investigational agents

- Patients with untreated central nervous system metastases or local treatment of brain
metastases

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to the agent used in study.

- Serious or uncontrolled intercurrent illness

- HIV-positive patients are ineligible

- Patients unwilling to use adequate contraception